UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II trial of percutaneous vertebroplasty combined with radiotherapy for vertebral metastasis
Acronym	Phase I/II trial of PVP+RT for vertebral metastasis
Scientific Title	Phase I/II trial of percutaneous vertebroplasty combined with radiotherapy for vertebral metastasis
Scientific Title:Acronym	Phase I/II trial of PVP+RT for vertebral metastasis
Region	Japan

Condition
Condition	vertebral metastasis
Classification by specialty	Hematology and clinical oncology Orthopedics Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of percutaneous vertebroplasty combined with radiation therapy for vertebral metastasis with symptomatic skeletal events
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	To evaluate short-time safety of percutaneous vertebroplasty combined with radiation therapy for vertebral metastasis with symptomatic skeletal events
Key secondary outcomes	To evaluate safety and efficacy of percutaneous vertebroplasty combined with radiation therapy for vertebral metastasis with symptomatic skeletal events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Percutaneous vertebroplasty Radiation therapy 30Gy/3fr/10times, 20Gy/4fr/5times, or 8Gy/1fr/1time
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)The terget lesion was diagnosed as vertebral metastasis. 2)The terget lesion was thoracic or lumber vertebrae. 3)The number of terget lesions was within 3.4)Bilsky Grade >= 1b 5)Patient has pain from the lesions under analgesic. 6)SINS >= 7 or SINS <= 6 and meet the below. a)Lytic lesions with > 1/3 vertebral body involved b)Lytic lesions with pain in mortion c)Lesions with vertebral collapse 7)The period of prognosis > 3 month
Key exclusion criteria	1)Patients can not maintain the position needed for treatment 2)Target lesions is cervical vertebrae or sacrum 3)The number of terget lesions was more than 4. 4)Bilsky Grade >= 1c 5)History of radiation therapy or surgery for target lesions 6)Bleeding tendency (Platelet counts <= 50,000 or PT-INR > 1.5) 7)Spondylitis or discitis 8)History of major drug allergy
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Okada
Organization	Kobe University Hospital
Division name	Department of Diagnostic and Interventional Radiology
Zip code	6500017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6104
Email	okataku@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Okada
Organization	Kobe University Hospital
Division name	Department of Diagnostic and Interventional Radiology
Zip code	6500017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6104
Homepage URL
Email	okataku@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	Kobe University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Hospital
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel	078-382-5111
Email	kainyu@med.kobe-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 15 Day
Date of IRB	2018 Year 03 Month 12 Day
Anticipated trial start date	2018 Year 03 Month 31 Day
Last follow-up date	2026 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 15 Day
Last modified on	2022 Year 08 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035613